Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

LONG TERM FOLLOW UP OF THE PHASE1/11 STUDY OF SAQUINAVIR, IN ASYMPTOMATIC OR MILDLY SYMPTOMATIC HIV INFECTION

V. Kitchen, C. Skinner*, E. Lane**, S. Galpin*, K. Bragman+, A. Pinching*** and J. Weber*.
*St Mary's Hospital Modical School, London W2, UK. **Roche Ltd, UK. ***St Bartholomew's Hospital Medical School, London EC2, UK. +Roche Intemational Clinical Research Centre, Strasbourg, France.

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 11.3
AIDS 1994, Vol. 8 (Suppl. 4);S10

To evaluate the long term safety, tolerability and activity of saquinavir, an orally active and highly selective inhibitor of the HIV proteinase, in a double blind, dose ranging study in asymptomatic or mildly symptomatic AZT naïve, positive subjects with CD. counts < 500 x 10⁶/ml.

Subjects were randomised to receive saquinavir at 25 mg, 75 mg, 200 mg or 600 mg tds. Data from the initial 16 weeks of this study have been presented previously (data on file Hoffman La Roche). We present data from those patients who elected to enter the double blind extension phase of the study (treatment duration 16-75 wks). Activity parameters were CD. number, p24ag, HIV plasma and PBMC TCID and DNA PCR. Viral resistance was measured at 52 weeks. Data are presented to March 93.

Forty subjects entered the double blind extension phase, of whom 34 completed and 6 prematurely withdrew. At least 1 subject in each treatment group received more than 64 weeks treatment, and 4 received at least 72 weeks therapy. Most of the adverse events, reported were mild and unrelated to trial treatment. There were no deaths and only one subject withdrew due to adverse events (diarrhoea and vomiting). No apparent dose-related effect on laboratory parameters was detected. Efficacy data have not been fully analysed to date, but will be available at the time of presentation.

Long term saquinavir therapy was very well tolerated in this patient population. The results of efficacy parameters will be discussed. In addition, the emergence of resistant viral mutations over the course of the study will be discussed.

Presenting author: V. Kitchen

1994-11-18
11.3

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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